We are a clinical stage biopharmaceutical company using our proprietary Precision Timed Release, or PTR, drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products designed to improve the lives of patients suffering from frequently diagnosed conditions characterized by burdensome daily dosing regimens and suboptimal treatment outcomes. We are initially focusing our efforts on the treatment of Attention Deficit/Hyperactivity Disorder, or ADHD. Our PTR platform incorporates a proprietary Erosion Barrier Layer, or EBL, designed to allow for the release of drug substance at specific pre-defined time intervals, unlocking the potential for once-daily multi-dose tablets.

We are initially targeting the ADHD stimulant-based treatment market, with an estimated U.S. market size of $15.3 billion in 2020. Stimulants are the most commonly prescribed class of medications for ADHD and account for more than 90% of all ADHD medication prescriptions in the United States.

Our two proprietary first-line stimulant medications: CTx-1301 (dexmethylphenidate) and CTx-1302 (dextroamphetamine), are being developed for the treatment of ADHD in the three main patient segments: children (ages 6 -12), adolescents (ages 13-17), and adults (ages18+). Both CTx-1301 and CTx-1302 are designed to address the key shortcomings of currently approved stimulant therapies: to provide an immediate onset of action (within 30 minutes); offer ‘entire active-day’ duration; eliminate the need for a ‘booster/recovery’ dose of short-acting stimulant medications; minimize or eliminate the rebound/crash symptoms associated with early medication ‘wear-off’ and provide favorable tolerability with a controlled descent of drug blood levels. Furthermore, by eliminating the ‘booster’ dose used by up to 60% of ADHD patients in conjunction with their primary medication, we believe our product candidates may provide important societal and economic benefits: reducing the abuse and diversion associated with short-acting stimulant medications; allowing physicians to prescribe one medication versus two; allowing patients to pay for one medication versus two, and allowing payers to reimburse for one medication versus two.

We completed a proof-of-concept trial in human subjects to validate our PTR platform and in October 2020, announced positive results from a Phase 1/2 study of CTx-1301 in ADHD patients establishing tolerability, comparative bioavailability and dose proportionality of CTx-1301 versus Focalin® XR. We plan to initiate Phase 3 trials in the fourth quarter of 2021 for CTx-1301 with results expected in late 2022. Assuming we receive positive clinical results from our pivotal Phase 3 trials for CTx-1301, we plan to submit a new drug application, or NDA, for CTx-1301 in the first half of 2023. In addition, we plan to initiate a Phase 1/2 bioavailability study in ADHD patients for CTx-1302 in early 2022 and, if the results from this study are successful, we plan to initiate pivotal Phase 3 clinical trials in all patient segments for CTx-1302 in late 2022 with results expected in early 2024.

(Note: This is a unit offering. Cingulate upsized its IPO at pricing on Dec. 7, 2021, to 4.17 million shares, up from 3.57 million in the prospectus, and warrants to buy 4.17 million shares of common stock – and priced the IPO at $6 – the low end of its $6-to-$8 range. The IPO raised $25.02 million. The stock is expected to trade under the symbol “CING” and the warrants are expected to trade under the symbol “CINGW” – both to debut on Wednesday, Dec. 8, 2021, on the NASDAQ. The amount raised slightly exceeded the $24.99 million in estimated proceeds under its revised terms in an S-1/A filing dated Nov. 10, 2021, which called for 3.57 million shares at $6 to $8 – with new joint book-runners, Aegis Capital Corp. and Laidlaw & Co. (UK) Ltd. Cingulate previously postponed this IPO, which had been expected to start trading on Oct. 15, 2021. SEC filings in October listed Oppenheimer & Co. as the sole bookrunner with Ladenburg Thalmann and Brookline Capital Markets as the co-managers. Cingulate cut the size of its IPO on Oct. 12, 2021, to 4.44 million shares – down from 4.55 million shares – and reduced the price range to $8 to $10 – down from $10 to $12 – to raise $39.96 million.)